Table 2 Inclusion and non-inclusion criteria
Inclusion criteria | Non-inclusion criteria |
|---|---|
Age ≥ 50 years old | Pregnant or breast-feeding womena |
Patients who signed the consent form | Patients with other acute or chronic intercurrent ocular pathology interfering with visual acuity or visual field (diabetes, drug-induced or other retinopathy, other optic neuropathy including uni- or contralateral glaucoma and/or intraocular pressure > 30 mmHg, advanced cataract, corneal opacities, amblyopia < 5/10, severe myopia > −6 diopters, retinal disease) |
Patients affiliated with a national health insurance scheme or beneficiaries of such a scheme. | Simultaneous bilateral NAAION, occurring 1 month apart or less |
Evidence or suspicion of other causes of optic neuropathies considered as main differentials: 1/ giant cell arteritis causing arteritic anterior ischemic optic neuropathy (AAION) 2/ Optic neuritis (based on clinical examination, personal history of multiple sclerosis, contributive ancillary investigations) and 3/ compression/infiltration of the optic nerves, based on the clinical findings and orbital/brain imaging. | |
Patients with systolic blood pressure below 100 mmHg | |
Patient with orthostatic hypotension (20 mmHg drop in SBP and/or 10 mmHg drop in DBP when moving to a standing position) | |
Neurological history of vascular or tumour-related changes to the visual field or other optic neuropathy | |
Systemic inflammatory disease | |
Known allergy to bosentan | |
Patients with moderate to severe hepatic impairment (Child-Pugh class B or C), biliary cirrhosis (serum levels of liver aminotransferases, aspartate aminotransferases (ASAT) and/or alanine aminotransferases (ALAT), greater than three times the upper limit of normal, bilirubin greater than twice normal) | |
Estimated glomerular filtration rate (GFR) < 30 ml/min/1.73 m2 | |
Patients treated with drugs whose efficacy may be reduced by activation of cytochrome P450, 2C9, 3A4 and 2C19 isoenzymes | |
Patients treated with amiodarone | |
Patients treated with one of the prohibited concomitant treatments in the study | |
Patient treated with systemic corticosteroids (background treatment or treatment initiated at the time of NAAION diagnosis) | |
Person deprived of liberty by judicial or administrative decision, adult protected by law, hospitalised person | |
Ongoing participation in another clinical research study or in the exclusion period of another clinical study |